Chemical name: 3-(3,5-dichlorophenyl)-2,4-dioxo-N-(propan-2-yl)imidazolidine-1-carboxamide Final regulatory action has been taken for the category: Pesticide Final regulatory action: The chemical is Banned Use or uses prohibited by the final regulatory action: Ban all formulation and for all uses. Pesticide use or uses that remain allowed: None The final regulatory action was based on a risk or hazard evaluation: Yes Summary of the final regulatory action: Based on the decision Nr 001/DNSA/2014 Iprodione was banned by the National Directorate of Agrarian Services from further import and use in Mozambique. The ban of all uses and the cancellation of the products containing Iprodione in the country was decided due to the toxic nature and hazardous properties of this active substance which combined with the improper use in the country due to the local specific conditions of use can damage human and animal health. The decision to ban the registration of the Iprodione was taken as the last step of the project for risk reduction of highly hazardous pesticides which identified highly hazardous pesticides that are registered in Mozambique. After consultations with different actors (public sector, private sector, civil society and others) cancelation of registrations and consequent ban and non-approval for their use in Mozambique was approved. The reasons for the final regulatory action were relevant to: Human health Summary of known hazards and risks to human health: A project entitled Reducing Risks of Highly Hazardous Pesticides (HHPs) in Mozambique was initiated by the Government of Mozambique with the objective to reduce the greatest risks associated with pesticide use in the country. The ultimate goal was to develop and implement an HHP Risk Reduction Action Plan for the most dangerous pesticides and use situations, resulting over time in the implementation of a variety of risk reduction measures based on a review of use conditions. In the first step of the project, a review of all the pesticides registered in Mozambique was carried out and a shortlist of highly hazardous pesticides was established. This shortlist was based on an assessment of the hazards of the pesticides, based on criteria established by the FAO/WHO Joint Meeting on Pesticide Management (JMPM) (FAO/WHO, 2008). During the second step of the project, a use survey was carried out in selected regions and cropping systems in Mozambique. The main goal of the survey was to identify the conditions under which pesticides are being used in the country and their contribution to potential risks for human health and the environment. The third step of the project consisted of a stakeholder consultation to further discuss the use and risks of highly hazardous pesticides in Mozambique and fine-tune the shortlist based on the survey results and the expertise and experience of stakeholders. As result, a short list of HHPs, including coming close to HHPs, which were used in the country, was established. Iprodione was on the short list as a pesticide coming close to HHPs based on the below indicated criteria: -Pesticides for which carcinogenicity evaluations by different registration/assessment authorities did not lead to consistent classification as GHS Category 1A or 1B, but which were, based on the evidence of one of these authorities, considered of particular concern for use in Mozambique (Come A.M.& van der Valk H., 2014). -Iprodione was classified by the US EPA as likely to be carcinogenic. It was registered in the US. However, all residential uses were cancelled due to cancer risk concerns. Also, back packer sprayers and mixers should wear double layer PPE, masks and gloves. Iprodione was registered in the EU. The EC review from 2004, classified Iprodione in Category 2 of carcinogenicity classification. The US proposed risk mitigation measures posed significant concern for Mozambican use situation. The final conclusion for the HHP assessment in Mozambique identified Iprodione as carcinogenic equivalent or similar to GHS Class 1A&1B, and therefore considered as coming close to HHPs. (Come A.M.& van der Valk H., 2014.) During the second phase of the project field surveys on the pesticide use and exposure were carried out. The surveys (325 subsistence farmers interviewed) revealed that most of the farmers applied pesticides (95%), and that the conditions of use were likely to result in undue (excessive) exposure. Half of the farmers interviewed never received any training on pesticides use, and even the other half that did, often lacked understanding of the risks involved. Farmers were spraying vegetable crops at least 14 times per growing season. One out of three applications was involving one of the HHP containing formulation (Farmers using HHPs includes almost 30% of the interviewed farmers). Also almost none of the farmers (93%) owned or wore adequate PPE having only one or no protective items at all. Only 2% of those applying HHPs wore adequate full body protection PPE. About half of the farmers had not received any training on the use of pesticides. The majority of pesticide applicators used manual sprayer (36%), followed by electric sprayer (with batteries); 33% and followed by inappropriate equipment such as watering can (13.5%) or other (unknown) means (12.5%). Approximately about half of the farmers surveyed reported that they noticed to receive pesticide on their clothes, bare skin or eyes when using pesticides. The main health symptoms associated with pesticide use by farmers noticing symptoms were headaches, skin rashes, burning eyes, vomiting, burning nose, blurred vision, dizziness and excessive sweating. Almost half of the farmers declared they did not read pesticide labels, including use instructions such as proper dosage and protective measures, the main reason being illiteracy. One out of four farmers poorly understood the hazard colour band on pesticide labels that indicates acute toxicity. The survey results showed that the use of pesticides in general, and of HHPs in particular, was likely to result in excessive exposure of farmers in Mozambique. Therefore enforcing risk mitigation measures depending solely on wearing the appropriate PPE under the local conditions of use to be difficult and unlikely to give results. Iprodione and the products containing this a.i. were considered as harmful for the human health taking into consideration of the local conditions of use in Mozambique requiring risk mitigation measures. Therefore, the authorities decided to ban the a.i. iprodione from future use in the country and to cancel the registration of all the products containing it. Expected effect of the final regulatory action in relation to human health: Reducing the risk posed by the use of HHPs in Mozambique specially Iprodione in the context of human health. Summary of known hazards and risks to the environment: N/A Expected effect of the final regulatory action in relation to the environment: N/A Date of entry into force of the final regulatory action: 15/07/2014 |